Mitochondrial Intervention for Resilience in Older Adults With Coenzyme Q10
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in plasma GDF-15 concentration
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial will investigate whether 10 weeks of CoQ10 supplementation can improve biological resilience and functional health in community-dwelling adults aged 65 years or older with signs of reduced biological resilience or prefrailty.
Participants will be randomly assigned in a 1:1 ratio to receive either 200 mg of CoQ10 daily or matching placebo for 10 weeks. The study will assess the effects of CoQ10 supplementation on mitochondrial functional resilience, chronic low-grade inflammation, metabolic health, physical performance, cognitive function, and objective measures of skin aging.
The study will also investigate whether baseline biological and functional characteristics can identify individuals who are more likely to benefit from CoQ10 supplementation. An exploratory aim is to develop a multidimensional composite index of biological resilience integrating molecular, biochemical, functional, and clinical measures of aging.
The study will provide evidence on whether a mitochondria-targeted intervention with CoQ10 may represent a potential strategy for improving functional resilience and reducing features of prefrailty in older adults.
详细描述
- Background and Rationale Population aging is associated with an increasing prevalence of chronic diseases, functional decline, cognitive impairment, frailty, loss of independence, and reduced quality of life. Traditional medical care of older adults has largely focused on the diagnosis and treatment of individual diseases. However, contemporary geroscience emphasizes that age-related functional decline is not solely a consequence of individual diseases but results from the interaction of fundamental biological mechanisms of aging affecting multiple organ systems.
An important concept within geroscience is biological resilience, defined as the capacity of an organism to maintain homeostasis, functional capacity, and regenerative potential despite internal and external stressors. Biological resilience reflects the integrated function of multiple physiological systems, including mitochondrial bioenergetics, metabolic regulation, inflammatory responses, cellular stress responses, and tissue regeneration. With advancing age, physiological reserve and the ability to adapt to stressors progressively decline. Clinically, this may manifest as prefrailty, which represents an intermediate and potentially modifiable state between healthy aging and established frailty.
Current approaches to preventing or treating prefrailty primarily include physical exercise, resistance training, nutritional optimization, adequate protein intake, and prevention of malnutrition. Although these interventions can improve aspects of physical function, their effects vary between individuals, and there is currently limited evidence for biological interventions specifically targeting fundamental mechanisms contributing to reduced biological resilience.
Mitochondrial dysfunction is considered one of the central mechanisms of biological aging. Mitochondria play a critical role in cellular energy production, oxidative balance, cellular stress responses, and metabolic adaptation. Impaired mitochondrial function may therefore contribute to reduced physiological reserve and may represent a potentially modifiable component of biological resilience.
Coenzyme Q10 (CoQ10) is an essential component of the mitochondrial electron transport chain and participates in ATP production. Its reduced form, ubiquinol, also has an important antioxidant function. CoQ10 availability decreases with age, potentially contributing to impaired mitochondrial adaptation to metabolic and oxidative stress. Previous clinical studies have demonstrated that oral CoQ10 supplementation can increase circulating CoQ10 concentrations and may influence oxidative stress, inflammatory responses, mitochondrial function, and physical performance. However, it remains unclear whether CoQ10 supplementation can improve the broader multidimensional phenotype of reduced biological resilience in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be quadruple-masked. Participants, care providers, investigators, and outcome assessors will be unaware of treatment allocation. CoQ10 and placebo will be provided in identical packaging and dosage forms to maintain blinding throughout the 10-week intervention. Treatment allocation will remain concealed until completion of the predefined study analyses, except when unblinding is required for participant safety.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years or older.
- •Community-dwelling older adult.
- •Presence of signs of reduced biological resilience or prefrailty, defined by meeting at least one of the following criteria:
- •Prefrailty according to the Fried frailty phenotype, defined as the presence of 1-2 of the following criteria: unintentional weight loss, self-reported exhaustion, reduced physical activity, slow walking speed, or reduced handgrip strength; or
- •Reduced physical performance, defined as a Short Physical Performance Battery (SPPB) score of ≤9; or
- •Increased functional vulnerability, defined as a Clinical Frailty Scale (CFS) score of ≥
- •Ability to understand the study procedures and comply with the study protocol.
- •Ability and willingness to provide written informed consent before participation.
排除标准
- •Established frailty with severe functional impairment that would interfere with study participation or outcome assessment.
- •Advanced dementia or cognitive impairment preventing informed consent or reliable participation in study assessments.
- •Active malignant disease or ongoing cancer treatment.
- •Acute inflammatory disease or acute infection at the time of enrollment.
- •Acute or unstable medical condition that could substantially affect functional performance, cognitive assessment, or the safety of the intervention.
- •Any medical condition considered by the investigator to make participation inappropriate or unsafe.
- •Current use of CoQ10 supplementation at a dose that could interfere with assessment of the study intervention, unless discontinued for the predefined washout period.
- •Known hypersensitivity or intolerance to CoQ10 or any component of the study product.
- •Participation in another interventional clinical trial that could affect the outcomes of the present study.
结局指标
主要结局
Change in plasma GDF-15 concentration
时间窗: Baseline to Week 10
Change in plasma GDF-15 concentration from baseline to the end of the 10-week intervention, comparing the CoQ10 and placebo groups.
次要结局
- CoQ10 availability(Baseline to Week 10)
- Additional mitochondrial biomarkers(Baseline to week 10)
研究者
Mišo Šabović
Prof. Mišo Šabović, MD, PhD
University Medical Centre Ljubljana